510(k) · Cleared

Recalled · Class II · 2017

Exactrac Vero

K122451510(k) TraditionalCleared Sep 28, 201246-day reviewClass II21 CFR 892.5050Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Brainlab AG · IYE Accelerator, Linear, Medical

Cleared on Sep 28, 2012 as substantially equivalent to K072046 (Brainlab AG, 2007) and 1 other predicate after a 46-day review. Its family tree reaches back 3 generations to 2001. 10 later devices descend from it. It has been recalled 2 times.

Decided: Sep 28, 2012
Review: 46 days
Class: Class II
Product code: IYE
Recalls: 2
Predicates: 2

Its longest line of descent runs back 3 generations to K003285 (2001). 4 ancestors in all. 10 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK003285 Exac Trac 2.0 (Novalis Body Module)Brainlab AG · 2001
2 generations backK040585 Exactrac 4.0 and Exactrac X-Ray 6DBrainlab AG · 2004
1 generation backK072046 Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac OemBrainlab AG · 2007
This deviceK122451 Exactrac VeroBrainlab AG · 2012
Descendant · cites it directly · 8 of its ownK131965 XVI R5.0Elekta Limited · 2013
Descendant · 2 generations on · 4 of its ownK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015 · Recalled
Descendant · 3 generations on · 3 of its ownK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016 · Recalled
Descendant · 4 generations on · 2 of its ownK173789 Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018
Descendant · 5 generations on · 1 of its ownK222047 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell…Elekta Solutions AB · 2022

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2013high 2 (2016) · low 0 (2014)2026

Most influential descendants

Showing 5 of 10 · See all

K131965XVI R5.0Elekta Limited · 2013 · cites it directly8descendants
K151561Leksell Gamma Knife IconElekta Instrument AB · 2015 · 2 generations on4descendants
K160440Leksell Gamma Knife IconElekta Instrument AB · 2016 · 3 generations on3descendants
K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018 · 4 generations on2descendants
K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB · 2022 · 5 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K003285	Exac Trac 2.0 (Novalis Body Module)	Brainlab AG	2001	—
−2	K040585	Exactrac 4.0 and Exactrac X-Ray 6D	Brainlab AG	2004	—
−1	K072046	Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac Oem	Brainlab AG	2007	—
0 (this device)	K122451	Exactrac Vero	Brainlab AG	2012	—
+1	K131965	XVI R5.0	Elekta Limited	2013	—
+2	K151561	Leksell Gamma Knife Icon	Elekta Instrument AB	2015	1
+3	K160440	Leksell Gamma Knife Icon	Elekta Instrument AB	2016	1
+4	K173789	Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon	Elekta Instrument AB	2018	—
+5	K222047	Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife -…	Elekta Solutions AB	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0
2016	2	0
2017	1	0
2018	2	0
2019	1	0
2022	1	0
2025	1	0

FIG. 1 — Lineage of K122451, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYE device

#1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K072046	Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac Oem Summary page 1 …ExacTrac@ Vero Common/Classification Patient Positioning System, Radiation Therapy, Charged-Particle, Medical Name: Predicate Device: ExacTrac 3rd Party (K072046) Synchrony®)Respiratory Tracking System (K120233) by Accuray Inc. Device classification System, Radiati…	Brainlab AG	2007	—
*	K120233	Synchrony Respiratory Tracking System Summary page 1 …, Radiation Therapy, Charged-Particle, Medical Name: Predicate Device: ExacTrac 3rd Party (K072046) Synchrony®)Respiratory Tracking System (K120233) by Accuray Inc. Device classification System, Radiation Therapy, Charged-Particle, Medical name: Regulatory Class: Class…	Accuray Incorporated	2012	1

Also cleared against K072046: 2 other devices →

What descends from it? (10)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K131965	XVI R5.0	Elekta Limited	2013	8
K181789	VeriSuite	Medcom GmbH	2018	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 3, 2017	Class II	Z-0172-2018	Software design	Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not…
May 4, 2016	Class II	Z-1929-2016	Device Design	Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
1 of the 4 ancestors has a recall of any class.
Of its descendants, K131965 (Elekta Limited, 2013) has gone furthest, with 8 descendants of its own.
2 other devices also cite its predicate K072046.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	23	44	78	155
2008	14	69	49	114
2009	20	63	22	174
2010	23	74	27	246
2011	11	94	73	280
2012	28	106	20	128
2013	18	88	11	96
2014	20	100	14	124
2015	20	108	8	100
2016	21	97	7	97
2017	23	94	7	125
2018	21	58	7	85
2019	19	83	2	91
2020	20	67	4	74
2021	19	86	5	68
2022	12	172	3	66
2023	18	129	7	128
2024	9	239	1	81
2025	12	170	1	101
2026	14	120	4	—

What is it indicated for?

ExacTrac Vero is intended to be used in conjunction with the MHI-TM2000 radiation therapy linear accelerator system manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. ExacTrac Vero uses…

Read the full statement (139 words)

ExacTrac Vero is intended to be used in conjunction with the MHI-TM2000 radiation therapy linear accelerator system manufactured by Mitsubishi Heavy Industries, Ltd.

ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator.

ExacTrac Vero uses stereoscopic x-ray or cone beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment.

Optionally ExacTrac Vero provides position data for the pan/tilt motion of the TM2000 gantry head to the MHI-TM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122451 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122451: Exactrac Vero.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122451

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026